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IRB Compliance Training

PIs and study team members are required to complete IRB compliance training prior to submission of a human subjects research eIRB application. For eIRB applications that are determined to be not human subjects research (NHSR), IRB compliance training is not required If the required courses have not been completed by the PI and all study team members prior to submission of the application, the application will be returned to the PI.

IRB Compliance Training Courses include:   

Basic Human Subjects Research (BHSR):

This online course provides a broad overview of the ethical background for regulations in human subjects research, as well as an overview of the IRB review requirements to be met before a human subjects research project may begin. This course is administered through the Collaborative Institutional Training Initiative (CITI).

Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application

Exceptions: Non-affiliated study members and Clinical Research Network (CRN) study team members may submit their compliance training certification for Basic Human Subjects Research (BHSR) from CITI, their local institution or another institution, such as NIH. As of June 1, 2012, if the compliance training certificate is more than five years old at the time of IRB submission, non-affiliated members will be required to take the JHM BHSR course. PIs and study team members listed on a NHSR eIRB application are not required to complete BHSR compliance training.

Conflict of Interest and Commitment (COI):

This online course is designed to introduce researchers to the topic of financial conflicts of interest in research, including what financial conflict of interest means, sources and risks of financial conflicts of interest in research, federal regulations and institutional policies designed to address the risks, and researchers’obligations under the regulations and policies. The federal government’s regulation on conflict of interest (COI) in research, which is intended to promote research objectivity, was revised in August 2012. This course is designed to fulfill the training requirements included in the regulation and in Johns Hopkins policy.

Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application who are JHU SOM and SON faculty, fellows, staff, and students; staff at ACH, APL, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, Cardiovascular Specialists of Central MD, Central MD Radiation Oncology Corporation, and part of the CRN.

Exceptions: CRN study team members may submit CITI or local institution conflict of interest training if it is not more than five years old at the time of IRB submission. If it is more than five years old, individuals must take the JHM IRB COI course. PIs and study team members listed on a NHSR eIRB application are not required to complete COI compliance training.

USF PIs, BSPH, Engineering, Arts and Sciences faculty, staff and students, and non-affiliated study team members are not required to complete this course.

HIPAA & Research -01 (H&R):

This online course covers specific HIPAA requirements for research involving health information.

Who needs it: PIs and study team members listed on a Convened/Expedited/Exempt eIRB application who are JHU SOM and SON faculty, fellows, staff, and students; staff at ACH, APL, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, USF faculty and staff, Cardiovascular Specialists of Central MD, Central MD Radiation Oncology Corporation; Engineering, Arts and Sciences faculty, staff and students. BSPH, CRN, and non-affiliated study team members (with the exception of USF) are not required to complete this course.

Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete HIPAA & Research compliance training.

Please note: The JHM IRB will not track completion of any Johns Hopkins HIPAA privacy courses (i.e., "Privacy for Health Care Providers" or "Privacy Refresher Course for Health Care Providers").

Clinical Research Billing Orientation (CRBO) and Clinical Research ManagementSystems (CRMS):

This online course introduces study team members to the improved clinical research billing process. Live training sessions, reference materials and start-up support will supplement this overview.

Who needs it: If there will be billing for study procedures, CRBO is required for PIs, and for study team members who will consent participants. When a new research application is submitted in eIRB, you will be notified by Clinical Research Support Services (CRSS) if you are required to take CRBO. If your study requires CRBO training, you will also be required to track study enrollment in the CRMS. CRMS training must be taken by the PI and the study team members responsible for entering data in the CRMS. 

Exceptions: PIs and study team members listed on a NHSR eIRB application are not required to complete CRBO or CRMS compliance training.

How do I Register?

 You must register for the required courses on the Hopkins myLearning website at:

You will be asked a few questions to determine your required courses, and then will be instructed to log in to myLearning to register for these courses.

myLearning will track your course completion. The BHSR course is administered through CITI. It will take 24 hours for the CITI course completion information to transfer to myLearning. Click on “My Learning History” on the left side navigation to obtain a copy of your course completion report. This report should be uploaded in the eIRB application (Section 2 – Study Team Compliance Training) if your training dates are not already displayed.

If you have already completed JHU SOM HSR, JHU SOM COI, or IRR, and you wish to receive a copy of the certificates, please contact the eIRB Help Desk at jhmeirb@jhmi.edu or 410-502-2092.

 

IRB Compliance Training Requirements for Human Subjects Research

Affiliation

BHSR

COI

HIPAA &
Research

CRBO/CRMS

Principal Investigators (PIs)

X

X

X

X

JHU SOM and SON faculty, fellows, staff, and students; staff at ACH, APL, JHH, JHCP, KKI, HCGH, Suburban Hospital, Sibley Memorial Hospital, Cardiovascular Specialists of Central MD, and Central MD Radiation Oncology Corporation

X

X

X

X

Engineering, Arts and Sciences faculty, staff and students

X

 

X

X

School of Public Health faculty, staff and students

X

  

X

University of South Florida PIs and study team membersX XX

Non-Hopkins study team members

X

  

X

Clinical Research Network study team members(AAMC, GBMC, INOVA, PRMC, RHS)

 X

  X

 

X

 


 


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